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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Resolute Integrity

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Study Status Completed
Application Number P110013 / PAS001
Date Current Protocol Accepted 02/17/2012
Study Name OSB Lead-Resolute Integrity
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, multi-center, non- randomized, single-arm, open-label study.
Study Population Description Patients with de novo lesions in native coronary arteries that meet the eligibility criteria and sign the informed consent form will participate in this study.
Sample Size The observed event rate for the primary endpoints is assumed to be 2% at 12 months so a sample size of 200 subjects will provide a 95% confidence interval [0.5%, 5%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of 230 patients will be conservatively enrolled in this trial to ensure that at least 200 patients will be evaluable at 12 months.

Centers (n≈30) are allowed to enroll a maximum of 40 subjects per center or until study enrollment has been completed, whichever comes first.

Data Collection Primary Endpoint

The primary endpoint for all patients enrolled in this study is the composite rate of cardiac death and TV MI at 12 months

Secondary Endpoints

Composite endpoints (hospital discharge, 30 days, 6 months, 12 months, and 24 months post-procedure):

¿ Major Adverse Cardiac Events (MACE)

¿ Target Lesion Failure (TLF)

¿ Target Vessel Failure (TVF)

¿ Cardiac Death and TV MI

Clinical endpoints:

¿ Death

¿ Myocardial Infarction

¿ Target Lesion Revascularization (TLR)

¿ Target Vessel Revascularization (TVR)

¿ Stent Thrombosis

¿ Stroke

¿ Bleeding complications in general

¿ Dual antiplatelet therapy (DAPT) compliance

In addition, the following will be assessed:

¿ Procedural success

¿ Device success

¿ Lesion success

Follow-up Visits and Length of Follow-up The length of follow-up is 2 years.

Frequency of Follow-up Assessments: 30 days, 6 months, 12 months, and 24 months post-procedure.

The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 12 months. The study will be conducted for a minimum of two (2) years from enrollment of the final subject.

Interim or Final Data Summary
Actual Number of Patients Enrolled 230 subjects
Actual Number of Sites Enrolled Thirty sites enrolled in the study; however, one site did not enroll any study subjects and was subsequently closed.

Patient Follow-up Rate 94.8% (218/230)
Final Safety Findings Primary endpoint: Cardiac death (CD) and target vessel myocardial infarction (TVMI) at 12 months: 3.5% (8/226, 95% CI: 1.5%-6.9%). It was expected that the composite rate of CD/TVMI will be consistent with the rate observed in the Resolute-US pre-approval trial (2% [95% CI: 0.5% - 5%]). The rate in this PAS does not seem to be much different. However, this PAS was designed to provide certain precision around the primary endpoint rate and not to test for differences in the studies¿ rates.

Secondary endpoints at 24 months:

Cardiac Death and Target Vessel Myocardial Infarction: 5.9% (13/219)

Target Lesion: 9.1% 9.1% (20/219) Target Vessel Failure: 12. 3% (27/219)

Major Adverse Cardiac Events: 11.0% (24/219) Death: 2. 7% (6/219)

Cardiac Death: 1.9% (4/209)

Target Vessel Myocardial Infarction: 4.1% (9/219)

Clinically Driven Target Lesion Revascularization: 5.0% (11/219) Clinically Driven Target Vessel Revascularization: 8. 2% (18/219)

Academic Research Consortium- definite/probable stent thrombosis: 1.9% (4/209) Stroke: 0.9% (2/219)

Bleeding Complications in General: 12. 8% (28/219) Dual antiplatelet therapy compliance: 65.1% (136/209)

Final Effect Findings Lesion Success1: 99.2% (243/245)

Device Success2: 99.2% (243/245)

Procedure Success3: 97.4% (221/227)

1 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method.

2 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

7 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.

Study Strengths & Weaknesses This study provides longer term (2 years) safety and effectiveness results of the Resolute Zotarolimus- Eluting Coronary Stent System. This post-approval study was conducted in the United States and had a very low lost to follow-up rate. This study confirmed the safety and effectiveness results of the premarket data on the Resolute Zotarolimus-Eluting Coronary Stent System.
Recommendations for Labeling Changes A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term (2-years) postmarket performance of the device.

OSB Lead-Resolute Integrity Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/17/2012 08/17/2012 On Time
one year report 02/16/2013 02/15/2013 On Time
18 month report 08/17/2013 08/16/2013 On Time
two year report 02/16/2014 02/18/2014 Overdue/Received
one year clinical report 10/03/2014 10/03/2014 On Time
Final Study Report 12/01/2015 09/30/2015 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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